MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 01/05/2015

Event Type  Injury  

Event Description

It was reported patient underwent a right partial knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to laxity.The tibial bearing was removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, excessive weight, and/or excessive unusual and/or awkward movement and/or activity.".

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent a right partial knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to laxity.The tibial bearing was removed and replaced.Patient was revised again on (b)(6) 2015 due to disease progression.All components were removed and replaced with a total knee system.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.Requested but not returned by hospital.

• Brand Name: OXF ANAT BRG RT LG SIZE 5 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estate; brigend IN CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4419567
• MDR Text Key: 5279168
• Report Number: 0001825034-2015-00209
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159584
• Device Lot Number: 2715501
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR